A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients

Simon Tremblay, PharmD, PhD2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2019年6月21日最近更新: 2020年5月13日

适应症

干预措施

试验速览

阶段: 4 期
发起方
入组人数: 60
试验地点: 2
主要终点: Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and female patients ≥ 18 years of age.
•Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
•Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
•The patient has given written informed consent to participate in the study

排除标准

•Patient has previously received an organ transplant other than a kidney.
•Patient is receiving an HLA identical living donor transplant.
•Patient who is a recipient of a multiple organ transplant.
•Patient has a most recent cytotoxic PRA of >25% or calculated PRA >50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
•Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
•Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with significant risk of rejection.
•Patient has received an ABO incompatible donor kidney.
•The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):
•Donor age ≥ 60 years OR
•Donor age 50-59 years and 1 of the following:
•i. Cerebrovascular accident (CVA) + hypertension + SCr > 1.5 mg/dL OR ii. CVA + hypertension OR iii. CVA + SCr > 1.5 mg/dL OR iv. Hypertension + SCr > 1.5 mg/dL OR c. CIT ≥ 24 hours, donor age > 10 years OR d. Donation after cardiac death (DCD)
•Recipients will be receiving a dual or en bloc kidney transplant.
•Donor anticipated cold ischemia is >30hours.
•Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included.
•Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.
•Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.
•Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
•Recipient who is seronegative for Epstein Barr Virus (EBV)
•Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
•Patients with thrombocytopenia (PLT <75,000/mm3), and/or leukopenia (WBC < 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
•Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
•Patient who has undergone desensitization therapy within 6 months prior to transplant.
•Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic acid, rabbit anti-thymocyte globulin, or glucocorticoids.
•Patient is receiving chronic steroid therapy at the time of transplant.
•Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years, unless they have an expected disease free survival of >95%.
•Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
•Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
•Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
•Inability to cooperate or communicate with the investigator.
•Renal allograft has been reperfused for more than 48 hours at the time of enrollment
•Patient unable to receive intact LCPT formulation